Therapeutics Goods Administration (TGA) Updates January – March 2017

Therapeutics Goods Administration (TGA) Updates January – March 2017

Updating Prescribing Medicines in Pregnancy database – April 03, 2017

TGA has updated the prescribing medicines for pregnant women they have added five new drugs to the database which as follows

  • Alectinib (pregnancy category D)
  • Cholic acid (pregnancy category B2)
  • Follitropin delta (pregnancy category D)
  • Progesterone (pregnancy category A)
  • Rurioctocog alfa pegol (pregnancy category B2)

Safety advice for consumer taking Sibutramine capsules – March 15, 2017

TGA has released safety advice on March, 15 2017 for people those are consuming herbal slimming capsules. Sibutramine capsules posses a serious risk to your health and should not be taken. The Therapeutic Goods Administration (TGA) has tested a product containing undeclared substance sibutramine. Consumers are advised that sibutramine is a prescription-only medicine (which was the active ingredient in Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events. Sibutramine capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

 

Stability testing for prescription medicines – March 06, 2017

This guidance applies to sponsors submitting applications to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG). It identifies the European Union guidelines for stability testing that have been adopted by the TGA for testing the active substance and the drug product

This guidance applies mainly to:

  • Prescription medicines containing active substances prepared by chemical synthesis
  • Prescription medicines containing active substances that are pure chemical entities isolated from a natural source (e.g. vincristine, digoxin)
  • Prescription medicines containing active substances produced by microbial fermentation (e.g. many antibiotics and some anticancer agents)
  • Radiopharmaceuticals
  • Biotechnological medicines
  • Biological medicines.

 

Homeopathic teething products – February 1, 2017

TGA is aware of overseas safety concerns relating to homeopathic teething products and is investigating the issue. The US Food and Drug Administration published a safety alert and media release stating that homeopathic teething tablets and gels may pose a risk to infants and children, based on that TGA is conducting urgent laboratory testing of homeopathic teething products currently marketed in Australia to ascertain whether any action is required or not. However, this does not exclude them from other provisions of the Therapeutic Goods Act 1989 in relation to quality and safety standards.

 

Shortage of Neo-Mercazole (carbimazole) – January 25, 2017

Consumers and doctors are advised that there was limited availability of Neo-Mercazole (carbimazole) 5 mg tablets, which was marketed in Australia by Amdipharm Mercury (Australia). Carbimazole is used in the treatment of hyperthyroidism. The shortage is due to a delay in the manufacturing schedule. TGA has imported and supplied a UK product, Carbimazole tablets 5 mg as a alternate usage product.

 

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